secwatch.observer — SEC 8-K summary
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Issuer:     Cullinan Therapeutics, Inc. (CGEM)
CIK:        0001789972
Form:       8-K
Filed at:   2025-12-08T23:59:59+00:00
Accession:  0001193125-25-310764
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cullinan Therapeutics reports 31% CR/CRh rate at 12 µg/kg for CLN-049 in R/R AML Phase 1
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- At 12 µg/kg (n=16), CR/CRh rate 31% (5/16) and CRc rate 31% (5/16); at ≥6 µg/kg (n=32), CR/CRh 25% and CRc 28%.
- In TP53-mutated AML patients at 12 µg/kg, 50% (4/8) achieved CR/CRh; 3 of 4 responses durable >16 weeks.
- 63% (5/8) of responders at ≥6 µg/kg had response >16 weeks; 2 patients proceeded to transplant.
- Safety: CRS mostly Grade 1/2 (35.6%), no Grade 3 with two step-up doses; no discontinuations due to CRS.
- FDA granted Fast Track designation; dose escalation continues with expansion cohorts planned early 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1789972/000119312525310764/0001193125-25-310764-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1789972/000119312525310764/cgem-20251208.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-310764

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